FIELD OF THE INVENTION
The present invention relates in general to surgical laser systems, and more particularly to a solid state artificial cornea for UV laser corneal sculpting.
BACKGROUND OF THE INVENTION
Corneal keratectomy is a surgical procedure which changes the refractive characteristics of the cornea by making deep incisions on the cornea. The procedure is used to eliminate or reduce eye disorders such as myopia, hyperopia and astigmatism.
Incision depth is the most critical factor in determining the refractive outcome to the keratectomy surgery. Results of the conventional technique are found to be inconsistent due to the use of steel or diamond knives. The corneal incisions have been found to vary considerably from the expected depth, with ranges from 66% to 96% for steel and 61% to 98% for diamond knife incisions.
It was discovered in or about 1981, that the corneal epithelium exhibits an unusual sensitivity to 193 nm laser light. Laser light of this wavelength was shown to be capable of etching organic substrates in or about 1982. It was then shown that this etching effect would similarly occur with biological tissue. More particularly, in 1983, in a series of experiments, (Trokel, S., Srinivasan, R. and Branen, B., Am. J. Opthal. 96:710 (1983)) the corneal stroma was ablated with an accuracy comparable to organic substrates.
The excimer laser is the most convenient source of UV laser light and has 193, 249, 308 and 351 nm light as major emission lines. These wavelengths span the UV spectrum and provide a suitable range with which to examine corneal tissue interactions. These four wavelengths can be produced at sufficiently high irradiance to cause corneal tissue ablation.
Therefore, the technique of UV laser keratectomy, was developed to replace conventional surgical corneal sculpting using diamond knives. The use of excimer lasers for corneal sculpting has proliferated during recent years.
The sharply controlled cutting/ablation ability of excimer lasers contrasts with the less controlled techniques which use the longer wavelength infrared laser frequencies which are also absorbed by corneal tissue. A CO2 laser, emitting light at 10.6 μm, produces an incision with irregular jagged edges, which chars the collagenous material of stroma (Keates et al 1981). This effect is quite unlike the uniform incisions produces by the 193 nm emission of the excimer laser. Consequently the excimer laser has developed into a preferred apparatus for corneal surgery.
Excimer lasers have been used to perform three types of refractive surgery. The first type uses the laser to create linear or circular excisions of corneal tissue, similar to conventional incision techniques. These incisions are effected to alter the mechanical stress patterns of the incised corneal stroma. In the untouched central cornea a new stress equilibrium is established, which produces a new optical curvature. The second type of refractive surgery involves ablation of surface areas of the cornea to create a new anterior curvature variously known as surface etching, reprofiling, surface ablation, and laser keratomileusis. The third type of refractive surgery involves removing tissue from discs of excised cornea in keratomileusis and epikeratoplasty.
Among numerous parameters that must be defined and controlled for these operations are the uniformity of the laser beam, the amount of radiant exposure, the energy distribution achieved on the cornea, the repetition rate of the laser, the total number of pulses, the total amount of energy delivered, as well as the shape and energy distribution of the laser beam as it impacts the cornea.
The underlying assumption for UV laser keratectomy is that if all of the individual parameters are set satisfactorily the overall result will be accurate. There are over ten parameters relating to this procedure. The above assumption ignores the interdependencies of these parameters. Currently there is no means of checking the overall result of these interdependencies on the actual cornea. For example, changing the intensity distribution of the beam will affect the energy per pulse and the resulting focusing characteristics. This in turn will affect the fluence on the cornea and ablation characteristics. If several of the parameters are readjusted prior to the operation then the overall result on the cornea becomes unpredictable.
The only way to ensure the repeatability of this surgical procedure is by characterizing the overall effect of the procedure on the cornea. A number of different lasers and surgical systems, each with a different number of parameters and optical path characteristics are currently being used. It is impossible to compare the results achieved with these intrinsically different systems.
It is also a well documented fact that excessive UV exposure to the eye causes and contributes to, among other effects, cataracts, uveal melanoma and photoreceptor insensitivity. Therefore, it is very important to determine and record the amount of UV radiation received by the eye during the operation. Currently, this in not being done during UV laser corneal sculpting surgery. Success of the operation is always judged after the operation.
SUMMARY OF THE INVENTION
According to the present invention, a system is provided for enabling surgeons to predict the results of UV laser refractive surgery before the surgery is actually performed on the patient.
The principle of the invention can be summarized as follows. After setting the above mentioned parameters, the surgeon performs the operation on a solid state artificial cornea. The artificial cornea displays the total energy distribution, in real time, as it would occur on the cornea during and after the surgery. Energy deposited on the corneal surface is directly related to the amount of material removed from the cornea. Thus the artificial cornea of the present invention allows the surgeon to determine how much ablation has occurred and where it preferentially has occurred. The surgeon can then decide if the distribution is satisfactory to achieve the maximum dioptre correction. If not, system parameters can be readjusted and the artificial cornea used again until the surgeon is satisfied with the results. Then, the surgery can be performed on the patient with confidence of an optimized response.
The artificial cornea of the present invention increases the safety and reliability of laser corneal sculpting, and allows comparison of the results independent of the laser and other parameters.
Furthermore, the artificial cornea of this invention allows surgeons to record the exact details of UV exposure during the surgery. The record is nonvolatile and permanent. Therefore, if further treatment is necessary in the future the surgeon will have an exact record of what had been previously done. Such a capability will also provide the means to perform accurate comparative studies of possible long term effects.
The system of the present invention can also be used for determining the energy profile of a laser beam prior to the operation. Laser power, transverse modes and energy density distribution are key parameters for characterization of the laser beam. The energy density distribution determines the quality of the etch pattern produced on the cornea. Currently this information is obtained by pyroelectric or calorimetric techniques. The required instrumentation is highly complicated and demands electronics expertise. The artificial cornea of the present invention produces the same information. This reduces the proliferation of complicated electronic equipment necessary for the surgery and allows the surgeon to focus on the task at hand.
In general, the present invention comprises an artificial cornea in the form of a solid state device which interacts with UV lasers where this interaction causes a distinctive and nonvolatile change of state in the device. The solid state components of the device are designed to be robust enough to withstand the laser pulse impact.
The UV sensitivity of the artificial cornea is tailored to match the human cornea's interaction with UV light. Means are also provided to control the sensitivity of the device to UV light.
Furthermore, according to the present invention, sophisticated graphic software may be provided to interface with the surgeon. The software allows the surgeon to assess the surgical data quickly and with minimal distractions.
BRIEF DESCRIPTION OF THE DRAWINGS
A description of the preferred embodiment of the present invention is provided herein below with reference to the following drawings, in which:
FIG. 1 is a schematic representation of a rotating slit UV surgical laser according to the prior art;
FIG. 2 is a schematic cross section of a recipient mask device (A) and donor mask (B) for use in laser corneal surgery according to the prior art;
FIG. 3 is a block diagram of an artificial cornea and test system therefor, in accordance with the preferred embodiment;
FIG. 4 is a schematic cross sectional view of a standard MOS transistor forming an EPROM cell adapted for use in the artificial cornea of FIG. 3;
FIGS. 5(a) and (b) are schematic cross sections of the standard MOS transistor cell of FIG. 4 showing electron flow during programming of the cell (a), and during erasure (b);
FIG. 6 is a further schematic cross section of the MOS transistor cell in FIGS. 3 and 4 showing electric field profiles with a positive floating gate potential;
FIG. 7 is a graph relating rate of erasure of an EPROM cell to photon energy of UV light applied thereto;
FIG. 8 shows a two-dimensional record of UV exposure of the artificial cornea according to the present invention at various depths of UV penetration;
FIG. 9 shows two-dimensional and three-dimensional profile records of UV exposure of the artificial cornea according to the present invention;
FIG. 10 is a block diagram of an artificial cornea and test system therefor, in accordance with a first alternative embodiment;
FIG. 11 is a block diagram of an artificial cornea and test system therefor, in accordance with a second alternative embodiment; and
FIG. 12 is a block diagram of an artificial cornea and test system therefor, in accordance with a third alternative embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
As discussed above, three techniques have evolved for the clinical use of excimer lasers for refractive surgery of the cornea. One approach uses the laser to create linear or circular excisions of corneal tissue, similar to conventional incision techniques. These incisions are made to alter the mechanical stress patterns of the incised cornea stroma. In the untouched central corneal a new stress equilibrium is established which produces a new optical curve.
Incisions are produced either by imaging with a slit located very near the cornea or by using an aperture and cylindrical lens. Various laser parameters for the radial keratectomy technique are summarized below in Table 1. Generally unstable resonators are used to reduce the beam divergence. The complete procedure takes about 15 minutes. The excimer exposure time for each excision in usually under 40 seconds. The total fluence of 1 joule/cm2 on the cornea ablates a depth of approximately 1 μm.
TABLE 1
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Fluence Etch
Energy on depth
Wave- per Fre- Cornea Per
length
Pulse quency mj/cm.sup.2 /
Pulse
(nm) (mj) (Hz) pulse (μm)
Reference
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193 80 10 threshold
Marshall
1985
193 100-250 1 50 threshold
Krueger
1985
249 100-250 1 185 threshold
Krueger
1985
308 100-250 1 540 threshold
Krueger
1985
351 100-250 1 1050 threshold
Krueger
1985
193 100-250 10 50 threshold
Krueger
1985
249 100-250 10 120 threshold
Krueger
1985
308 100-250 10 500 threshold
Krueger
1985
351 100-250 10 1000 threshold
Krueger
1985
193 100-250 25 55 threshold
Krueger
1985
249 100-250 25 80 threshold
Krueger
1985
308 100- 250 25 420 threshold
Krueger
1985
351 100-250 25 900 threshold
Krueger
1985
193 100 10 Cotliar
1985
193 1-20 100-200 Trokel
1982
193 30 165 Seiler
1988
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The second approach directly affects the optical center of the cornea where ablation of tissue from the central region defines a new refractive surface.
FIG. 1 illustrates a surgical arrangement of effecting UV laser corneal ablation according to this second technique.
The arrangement comprises a novel laser beam delivery system which produces a nonuniform, smooth surface ablation of the cornea. The laser beam 1 illuminates a rotating disk 3 which contains a single radial slit extending out from the center in the shape of a feather (i.e. widest at the middle). The shape of the slit is determined mathematically to perform a parabolic profile of correction for myopia that results from the slit rotation. The pulsed beam is reflected off of a mirror 5 and then focused via lens 7 onto the corneal surface of the eye 9. The ablation takes its maximal value at the center on the visual axis and its minimal value (zero) at the periphery of the carved zone.
Conceptually, the ablation profile is a function of the initial radius of curvature of the cornea. To correct myopia the ablation profile should vary from maximum at the centre of the cornea to minimum at the edge, hence decreasing the corneal curvature and refractive power at that area. The total amount of tissue ablated is a function of laser energy fluence, total area of the rotating slit 3, the angular rotational velocity of the slit and the repetition rate of the laser.
Many other types of delivery systems have also been designed to project a desired configuration of the laser onto the surface of the cornea. These include masks and diaphragms (discussed in greater detail below with reference to FIG. 2), as well as slit shapes.
To correctly characterize a UV laser keratectomy operation, all of the above mentioned variables along with various other laser and optical path related variables have to be strictly defined and recorded. Such proliferation of parameters makes it very difficult to replicate and compare the results of operations performed at different dates and locations. If the total energy density deposited on the cornea is recorded along with the number of pulses the characterization process becomes simple, reliable and repeatable. The artificial cornea of the present invention is designed to facilitate such a simplification.
Table 2 summarizes laser parameters for the keratectomy operation.
TABLE 2
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Fluence Etch
Energy on depth
Wave- per Fre- Cornea Per
length
Pulse quency mj/cm.sup.2 /
Pulse
(nm) (mj) (Hz) pulse (μm)
Reference
______________________________________
193 167 20 200 0.17 Hanna
1988
193 200 10 85-100 0.1-0.3
Del Pero
1990
193 160 5 250 0.45 Fantes
1990
193 200 10 85-100 0.1-0.3
Taylor
1989
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The third method involves noncontact trephination of recipient and donor corneas for the epikeratoplasty operation. Since the first successful keratoplasty, performed by E. Zirm in 1906, the basic surgical technique has not changed. Despite advantages in manual and motorized mechanical trephine design, high and irregular astigmatism still is a major factor limiting the functional results of penetration keratoplasty.
An important consideration for the keratoplasty operation is the effect of external pressure on the resultant trephine cut. Because of the lamellar structure of the cornea, every mechanical trephination necessarily requires pressure. This pressure causes both a torsion of the tissue in the cutting direction and the lateral deviation of the cut, creating a curved cut edge in cross section.
Excimer laser trephination is a non contact procedure. Therefore, cut deviation is totally eliminated. The direction of the corneal incision depends on the angle of incidence of the UV laser. Depending on the type of mask utilized it is possible to produce circular or elliptical buttons.
FIG. 2 illustrates the use of donor masks and recipient masks according to this prior art technique.
The laser parameters for this surgical procedure are as follows: wavelength 193 nm, frequency 30 Hz, and fluence at the cornea 700 mj/cm2. The exposure time varies between three and four minutes for a 8 mm circular trephination.
The excimar laser has a great potential for clincal application in corneal surgery. The corneal stroma, which is composed primarily of an extracellular matrix with few cells and with no blood vessels is an excellent biological target for UV ablation. To establish this technique among other standard techniques, reliable long term studies are necessary. A permanent and accurate record of the corneal ablation process provides the means for such a study.
According to a broad aspect of the present invention an artificial cornea is provided for sensing and integrating exposure to UV radiation and creating a permanent record of such exposure. The sensing and integrating may be effected by various means such as UV curable resins, recording UV phosphorescence via CCD camera, etc. According to the preferred embodiment, an EPROM like array of MOS transistors are arranged to form an articial cornea for measuring and integrating UV radiation in real time.
With reference to FIG. 3, an artificial cornea 31 is shown connected to a computer 33 for sensing and measuring UV radiation from an opthalmologic excimer laser 35 (e.g. ExciMed UV200™ excimer laser manufactured by Summit) controlled by an excimer laser controller 37 (e.g. Summit UV200 Controller) in conjuction with a power meter 39. The laser 35, controller 37 and power meter 39 are of standard design and the operation and construction thereof would be well known to a person skilled in the art.
Collimated laser light output from excimer laser 35 is optically processed via a beam mixer 41, beam splitter 43 and variable aperture 45, in a well known manner. The processed beam is then reflected via a mirror 47 and split into two beams via a further beam splitter 49. One of the split beams passes through a first focusing element 50 while the other beam is reflected off of a mirror 51 and passes through a second focusing element 53 (e.g. lens). The first split beam then passes through a shutter (e.g. such as the rotating disc 3 in FIG. 1) for application to a human cornea. The second split beam is focused onto the artificial cornea 31 for sensing and recording UV radiation.
As discussed in greater detail below, the artificial cornea preferably comprises an EPROM array 32 of MOS transistors 11 each of which is set prior to irradiation with UV light, and respective ones of which are erased in response to being irradiated.
The EPROM array 32 is connected to a controller/interface device 55 for reading and writing data into the array 32. The device 55 is connected to a peripheral port of computer 33 for effecting communication therebetween. In particular, computer 33 generates signals for setting all transistors 11 (FIG. 4) prior to irradiation. The artificial cornea 31 is then irradiated such that predetermined cells or MOS transistors thereof are erased, as discussed in greater detail below with reference to FIGS. 4-7). The computer 33 then reads the locations of EPROM array 32 and creates an irradiation profile or record in two-dimensions and three-dimensions, as shown in FIGS. 8 and 9). Any suitable data acquisition and graphics software may be used to create the irradiation record. For example, at the time of filing this application, computer 33 executed the Graftool™ graphical analysis system by 3D Visions Corporation for generating the profiles shown in FIGS. 8 and 9.
Turning to FIG. 4, a MOS transistor 11 is shown with the addition of a floating gate 13 buried in the insulator 17, 18 between the substrate 15 and the select gate electrode 19. As a result, the select gate voltage is capacitively coupled in series with the floating gate rather than directly to the underlying channel. Charge stored on the floating gate 13 alters the threshold voltage of the device 11 as detected at the top of the select gate 19.
The cell is programmed by charging the floating gate 13 via the injection of so-called hot electrons from the drain pinch-off region (FIG. 5(a)).
The cell is erased through internal photoemission from the floating gate 13 to the top gate 19 and substrate 15. Ultraviolet light gives electrons on the floating gate 13 enough energy to surmount the energy barrier between the floating gate and the insulator 17, 18 surrounding it.
The charge on the cell floating gate 13 changes the threshold voltage of the select gate 19 by an amount ##EQU1## where C is the capacitance between the floating gate 13 and the select gate 19 and ΔQFG is the change in charge on the floating gate. When the cell 11 is programmed, the negative charge on the floating gate 13 causes the floating gate-to-source voltage to be negative. This turns the cell 11 off, even with a positive voltage applied to gate 19.
Since the floating gate 13 is not tied to a power supply, its voltage is determined by its charge and by capacitance coupling to the voltages of the select gate 19, the drain 21, the channel 23 and source 25.
The hot electrons get their energy from the voltage applied to the drain 21 of the cell 11. They are accelerated along the channel 23 into the even higher fields surrounding the drain depletion region (FIG. 5(a)). While traversing the channel 23, the electrons enter a region where the electron field in the substrate 15 is about 105 v/cm greater. At this point the rate of energy gained from the electric field can no longer be described by the temperature of the silicon; hence the term "Hot". Once these electrons gain sufficient energy they can surmount the energy barrier between the silicon substrate 15 and the silicon dioxide insulator 18. Because energy loss due to phonon emission increases at higher lattice temperatures, it is actually easier to obtain hot electrons at lower operating temperatures.
In addition to phonon emission, hot electrons may give up some of this energy in another way: through electron-hole pair creation resulting from impact ionization. This phenomenon is observed in ordinary MOS transistors as a result of the onset of substrate current at high drain voltages. However, in the embodiment of the present invention, significant current multiplication produces substantial substrate current even before a large enough drain voltage is reached to produce hot-electron injection into the oxide 18.
With positive drain and channel voltages, electrons injected into the oxide layer 18 return to the substrate 15 unless a high positive select-gate voltage is applied to pull the electrons toward the floating gate 13. Not only does the floating gate have to be positively biased with respect to the source, it must also be positive with respect to the point along the channel 23 where hot electron injection occurs.
Near the beginning of the injection process, the inversion layer 27 extends almost completely to the drain 21, and the field in the oxide is attractive except for a small portion very near the drain (see FIG. 6). Current begins to flow through the oxide 18 at the point where the electrons are their hottest and where the oxide field is most favorable. As the floating gate 13 charges up, the floating gate-to-source voltage drops and the drain pinch-off region 29 moves toward the source 25. The surface field near the drain 21 intensifies and more hot electrons are produced in the substrate 15.
However, as seen in FIG. 6, in the region where the electrons are their hottest, the oxide field is least favourable for injection and so the injected-electron current begins to subside. Thus, the electron injection process is self-limiting. The charging of the floating gate 13 reduces the number of electrons that can be accelerated in the high field region. As the floating gate 13 becomes fully charged, the oxide current is reduced almost to zero because the oxide field is repulsive to the electrons injected into the high-field region.
Cell erasure is accomplished by exposing the array to UV light. Photons are absorbed by electrons in the conduction and valence band of the polysilicon floating gate 13 at erasure UV wavelengths, most are absorbed within approximately 50 Å of the oxide interface. The excited electrons leave the polysilicon floating gate 13, enter the oxide 17, 18 and are swept away to the select gate 19 or substrate 15 by the local field. During erasure, the select gate 19, source 25, drain 21 and substrate 15 are all near ground potential.
With an n-type polysilicon floating gate 13, electrons can be excited from either the conduction band or the valance band to the oxide 17, 18. Excitation from the conduction band requires only 3.2 eV, while the barrier height from the valence band is 4.3 eV. Even for heavily doped n-type material there are many more electrons available from the valence band of the polysilicon floating gate than from the conduction band.
Quantum yield and the erasure rate per incident photon follows the square law dependence upon photon energy shown in FIG. 7. Two distinct threshold energies are apparent (see FIG. 7). The first, at 3.2 eV, is associated with the photo-excitation of electrons from the conduction band. Its slope is much shallower because of the lower density of electrons. The 4.3 eV threshold corresponds to the onset of photoemission from the valence band. The much steeper slope is indicative of much higher density of valence band electrons.
Tables 3 and 4 provide some data on the absorptivity (A) and the absorption coefficient (α) for various elemental and compound semiconductors at excimer laser wavelengths.
TABLE 3
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Absorptivity calculated from
(n,k) for selected semiconductors at 300° k..
Wavelength (nm)
Material 308 nm 248 nm 196 nm
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Ge 0.44 0.35
Si 0.41 0.33
GaP 0.55 0.42
GaAs 0.58 0.33
GaSb 0.42 0.41
GeTe 0.59 0.75 0.80
InP 0.62 0.39
InAs 0.61 0.42
InSb 0.39 0.46
PbS 0.53 0.62 0.82
PbSe 0.29 0.50 0.77
PbTe 0.59 0.5 0.77
SnTe 0.49 0.66 0.75
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TABLE 4
______________________________________
Absorption coefficient α(10.sup.6 cm.sup.-1)
for various semiconductors at
300° K. and excimer wavelengths.
Wavelength (nm)
Material 308 nm 248 nm
______________________________________
Ge 1.35 1.62
Si 1.54 1.81
GaP 0.88 1.84
GaAs 0.78 2.07
GaSb 1.48 1.30
InP 0.70 1.77
InAs 0.73 1.46
InSb 1.50 1.24
PbS 0.92 0.82
PbSe 0.75 0.62
PbTe 0.80 0.67
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Thus, according to the present preferred embodiment of the invention, an EPROM like array 32 is utilized for sensing and integrating UV exposure in an artificial cornea 31. The EPROM like array 32 is preferably provided with a variable erasing threshold. Prior to a UV laser keratectomy operation, all of the bits of the EPROM like array 32 must be set. When the UV laser 35 is focused on the active area of the artificial cornea 31, the UV radiation will cause localized erasures. By monitoring via computer 33, in real time, the locations of the erased bits and the number of pulses required to achieve the given erasure distribution on a focal spot, a three dimensional map of the energy distribution can be obtained (FIGS. 8 and 9). To achieve this, the delicate semiconductor surface of the EPROM like array 32 has to be protected from the intense laser light without affecting the erasure threshold sensitivity. Furthermore the sensitivity levels have to be matched, either electronically or through software, to the ablation characteristics of the cornea.
Other embodiments and variations of the invention are possible within the scope of the present description. For example, while the use of an EPROM like array 32 to detect and integrate UV radiation is preferred, other detection and integration methodologies may be utilized. FIG. 10 shows an artificial cornea in the form of a quantity of UV curable resin 61 supported on a vertically adjustable platform 63 within a cup 65. Portions of the resin 61 which are irradiated 61' become cured, the platform 63 is then lowered for irradiating the next layer of uncured resin 61. The curing profile then provides an indication of the radiation exposure of the artificial cornea. In this embodiment no computer is required. In the embodiments of FIGS. 11 and 12, a CCD camera 71 is used to detect UV exposure. In the embodiment of FIG. 11, a UV sensitive CCD camera is used to directly detect the UV exposure. In the embodiment of FIG. 12, the UV radiation is applied to a sheet of UV sensitive material 73 which phosphoresces in response to being irradiated. A standard CCD camera 71 is then used to detect the phosphorescencess thereby generated. The output of the camera 71 in the embodiments of FIGS. 11 and 12 is applied to computer 33 for further analysis and graphical display.
All such embodiments and variations are believed to be within the sphere and scope of the present invention as defined by the claims appended hereto.